Cleared Traditional

K960944 - PPV VAPORIZER (MODIFICATION)

K960944 is an FDA 510(k) clearance for PPV VAPORIZER (MODIFICATION), manufactured by Penlon , Ltd.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K960944 · Penlon , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
49d
Days
Class 2
Risk

K960944 is an FDA 510(k) clearance for the PPV VAPORIZER (MODIFICATION). Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Penlon , Ltd. (Oxonn, GB). The FDA issued a Cleared decision on April 2, 1996 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K960944

510(k) Number K960944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date April 02, 1996
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAD Vaporizer, Anesthesia, Non-heated

All 41
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K960944.
DRAGER-VAPOR 2000
K971923 · Draeger Medical, Inc. · Sep 1997
TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
K952083 · Clover Medical Equipment Services, Inc. · Oct 1996
QUIK-FIL VAPORIZER KEYED FILLER
K961468 · Penlon , Ltd. · Jul 1996
TECHNOFIL
K953748 · Technimeca Medic, Inc. · Jan 1996
TECHFIL
K954801 · Technimeca Medic, Inc. · Jan 1996
DATUM
K942799 · Blease USA, Inc. · Apr 1995